Company: Epizyme, Inc.
Tazarotene lotion 0.045%
Trade Name: Arazlo™
Company: Ortho Dermatologics, Bausch Health
Approval Dates/Comments: The FDA approved this new preparation of tazarotene in December 2019 for the topical treatment of acne vulgaris in patients 9 years of age and older. Tazarotene lotion 0.045% is the first tazarotene acne treatment available in a lotion form, and clinical investigations demonstrated strong efficacy with favorable tolerability. The regulatory approval was based on data from two Phase 3 multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance (p<0.001). The drug was also shown to be well-tolerated in the clinical study population. In a Phase 2, head-to-head study comparing tazarotene lotion 0.045% (Arazlo™) and tazarotene cream 0.1% (Tazorac®), the findings demonstrated similar treatment success rates and comparable reductions in both inflammatory and non-inflammatory lesions over 12 weeks. While there were no significant differences in patient satisfaction or quality of life between the two treatments and both were well-tolerated, there were twice the number of treatment-related adverse events with tazarotene cream 0.1% (5.6% with Tazorac® versus 2.9% with Arazlo™). The most frequent adverse events reported with Arazlo™ (greater than 1%) were application site pain, dryness, exfoliation, erythema and pruritus.
Rituximab biosimilar for IV injection
Trade Name: ABP 798
Company: Amgen, Allergan
Approval Dates/Comments: In December 2019, Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar candidate to Rituxan® (rituximab). Rituxan is a CD20-directed cytolytic antibody that has been approved for hematologic and autoimmune indications, including the treatment of adult patients alone or in combination with chemotherapy for non-Hodgkin’s lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids.